Study to evaluate the effect of chondroitin sulfate on the synovitis in patients with knee osteoarthritis

Pilot, open-label, prospective, longitudinal, parallel study to evaluate the effect of chondroitin sulfate treatment effect in synovitis measured by ultrasonography in knee osteoarthritis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64282813

Enrollment

Registered

2014-11-20

Start date

2008-10-01

Completion date

Unknown

Last updated

2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

The participants will be randomly assigned to one of 2 study groups: 1. Chondroitin sulfate: 800mg orally once daily 2. Acetaminophen: 3g orally once daily Both treatments will be taken for 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men or women 40 years or older 2. Fulfilment of the American College of Rheumatology (ACR) classification criteria for clinical KOA 3. Presence of radiographic OA in the knee joint, defined as a Kellgren and Lawrence (K&L) score of 2 or 3. 4. Ultrasonography presence of synovitis plus joint effusion thickness =4 mm

Exclusion criteria

Exclusion criteria: 1. Any serious disease (such as decompensate heart disease, diabetes, fibromyalgia, renal insufficiency, liver disease or malignancies) 2. Secondary OA 3. Use of any medication already know to affect the variables examined (oral corticosteroids, intra-articular corticosteroids, or any SYSADOA within 3 previous months before study enrolment, or any nonsteroidal anti-inflammatory drug within 30 days before study?s enrolment)

Design outcomes

Primary

Measure	Time frame
Synovial hypertrophy and effusion measured by ultarsonography. The patient will be examined with the knee in 45 degree flexion and in full extension. The maximal values for synovitis and effusion will be measured in millimetres (mm) in the suprapatellar recess in the longitudinal axis using a 7-12 MHz linear array probe. All measurements will be carried out by the same investigator, who will be blind to the patient?s treatment regimen.	—

Measure

Time frame

Synovial hypertrophy and effusion measured by ultarsonography. The patient will be examined with the knee in 45 degree flexion and in full extension. The maximal values for synovitis and effusion will be measured in millimetres (mm) in the suprapatellar recess in the longitudinal axis using a 7-12 MHz linear array probe. All measurements will be carried out by the same investigator, who will be blind to the patient?s treatment regimen.

—

Secondary

Measure	Time frame
1. Pain of the studied knee using a patient?s self-assessed 10 cm visual analogue scale (VAS) 2. Joint function improvement using the Lequesne index 3. Synovial and serum human ILs (IL-1b, IL-6, and IL-8), chemokines (CXCL16, MCP-1, RANTES, and fractalkine) and neuropeptides (VIP, CRF, and UCN) levels will be measured through Luminex-based multiplex assay, ELISA and enzyme immunoassay kits	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026